The stem cell clinic industry selling unapproved “therapies” is ubiquitous and yet somehow still growing it seems. Many of us are encountering more of them including via ads and the clinics are basically all over the place.

What should someone do if they see a stem cell clinic that is particularly concerning?

A lot of people are asking me this question lately.

There are a variety of options depending on your level of concern, but below is a guide to possible actions you can take via agencies such as the relevant state medical board, the FDA and the FTC.

To be clear, not all stem cell clinics rise to the level of being “sketchy” and some are even compliant with FDA regs even if I’m skeptical that what they are doing is effective, but there are loads of seriously bad clinics out there.

If you feel a situation is especially dangerous due to adverse outcomes or other unique concerns, drop me a note by email and I can try to help in some way.

Otherwise, what can you try to do to make a positive difference?

State Medical Boards

A good place to start is with your state medical board.

Where specifically?

This will depend on your specific state. Usually state medical boards have contact phone numbers and/or emails on their websites. A quick web search usually pulls up the medical board for your state.

Here in my state, for instance, the Medical Board of California website has helpful resources (e.g. see screenshot) and you can also file a complaint by email here. You can complain about risky stem cell clinics in Texashere and in Floridahere.

Because state medical boards regulate physicians (and technically not their clinics it seems), you will need to know the name of the physician at the clinic to include that in raising your concern. Complaints to medical boards and potential action by the boards are taken very seriously by physicians, perhaps in some ways more seriously than worries of possible FDA action.

The Federation of State Medical Board (FSMB) issued a report largely on stem cell clinic issues earlier this year that suggests they are possibly going to take on the problem more directly than in past years. We’ll see how that goes.

Chiropractor regulators

As I was writing the above section on state medical boards an interesting question came to mind: who regulates chiropractors? It’s not medical boards. Normally it wouldn’t be the FDA either, although since chiropractors are now involved in injecting unapproved stem cell drugs, the FDA should get involved. The more direct regulation of chiropractors comes from state chiropractic boards (it seems all states have them). I would turn to them to file a complaint.

There’s also something called the The National Board of Chiropractic Examiners at the federal level, but they just seem to do licensing tests. I’m not sure if this other organizationwould do any good.

Would any of these do anything meaningful about chiropractors administering risky stem cells in an unethical manner for profit? I don’t know, but it’s a real and growing problem someone needs to address.

FDA

You can reach out to the FDA to let them know your concerns. The FDA is a very big organization so where specifically can you make a complaint or raise a concern? There are various options. You can start with an email to: [email protected]. Will the FDA do something concrete in response to your concern? It’s hard to say and if they do take action it might unfold over a long period of time.

FTC

A very large number of clinics make questionable marketing claims about their “stem cell” offerings, ranging from wild claims of cures for incurable diseases to implying their product has living stem cells when it doesn’t.

Screenshot from FTC website, arrow pointing to where to click to file a complaint

I asked the FTC what people should do if they are concerned about a stem cell clinic. You go to the FTC website and in the upper right corner you click on “Fire a consumer complaint”, which I highlighted with the red arrow in the image above. Then click through the various choices. I would recommend clicking “other” as the category and then “health and fitness”.

The FTC took action on two stem cell clinics and their owner this year, but if there might be 800 clinics out there now and many of them making false claims, the FTC needs to do a lot more.

Hosts of Ads

Depending on where you saw an ad for the clinic, you could contact the entity who is running the ad like Google, your local paper, etc. to complain.

What to say

What should you say in your complaint about a stem cell clinic?

It will depend on who you are talking to you. I would emphasize concrete reasons for concern such as the use of an unapproved stem cell drug product by the clinic, a physician practicing outside their area of expertise so putting their patients at risk, false marketing, and potential or documented (if they’ve already happened) patient harms. For some clinics that aren’t led by physicians, I would also emphasize the risks of non-physicians such as chiropractors or Ph.D.s doing procedures for which they aren’t trained or licensed. I think patients (or people communicating on their behalf) making complaints about clinics and their personnel will have the greatest impact.

In the long run

We can make a difference by pushing back on the worst clinics. Of course, not every action by those of us in the stem cell arena who are concerned about predatory clinics will hit a bullseye to make real change, but sometimes it has happened in the past and will happen again in the future too.

5 Comments

Thanks for taking the lead on this ! Those of us who are trying to do the right thing in this space have been quite frustrated but what we see going on. As incoming President of the Interventional Orthopedic Foundation (IOF) and a board member of AARM, I will be making this a priority issue along with creating standards and guidelines and proper education (at least in the application of Orthobiologics for Orthopedic conditions). I am also actively working on creating a NATIONAL outcomes database that will be of low cost but very user friendly for thoughtful clinicians and patients.
I am looking forward to working with you and others on these issues !

Filing a complaint on the basis of “a Physician practicing outside their area of expertise so putting their patients at risk” seems at least questionable to me. I don’t think that is a very valid reason in ALL instances. Personally, the REGENERATIVE MEDICINE CLINIC (what Dr. Knoepfler calls a STEM CELL CLINIC) that has treated my arthritic knees employ a team of physicians none of which are or were orthopedic surgeons. But, certainly they have training relative to sports medicine and rheumatology. Most, but not all of them, are board certified in, for example, Physical Medicine and Rehabilitation and one was an Army General Surgeon. There is a lot of crossover in what most would consider separate practices of medicine and surgery. On at least two occasions, one of my regenerative medicine clinic’s nurses, with additional graduate level training, injected my knees utilizing PRP (NOT STEM CELLS!!!) as well as ultrasonic imaging/guidance. In my estimation she was very competent and knowledgeable though neither a physician nor a surgeon. I have nothing but praise and zero complaints about her.
Now, I will admit, I would rather a Physician have been trained in, for instance, Neurology or Cardiology if they are treating patients with their own BODY PARTS for conditions relative to MS or congestive heart failure. But these fields have not yet evolved into regenerative procedures at least not entirely. Regeneration as a practice of medicine has to my knowledge, no residency program or fellowship similar to other fields of medicine and surgery. In my opinion, slowing things down with IND’s, IRB’s, BLA’s, perpetual research and other forms of bureaucracy is not helping things either. In fact quite the opposite. Like politics, there is entirely too much money in the current practice of medicine with a whole host of players benefiting from that status quo like medical device manufacturers, insurance companies, biomedical researchers, drug companies and patent attorneys to name a few. Multipotency, not Pluripotency, has the potential to revolutionize this current industrial status quo which is the essential reason it is not being embraced in my opinion. Medicine and research ought to be conducted first and foremost as a service and not a business. I do not think that is necessarily the case today.

As far as the chiropractic groups, every state department of health is going to have a chiropractic regulatory arm under the department of licensing. They enforce consumer complaints are required by law to investigate complaints. There are plenty of good compliant chiropractors offering cell therapy and regenerative medicine when combined with physicians in a multidisciplinary setting, and then there are those intravenously administering amniotic tissue allograft and umbilical cord “stem cells” utilizing “for-hire” mid level providers. These are the sketchy ones to be aware of.

NO. They are all sketchy becasue they do not understand the basic immunobiochemistry responsible for any effect from the cell based therapy. Ridiculous statement. Needs to be an orthopedic surgeon who can solve any complications that arise, and we all know that a LOT of complications come from this crowd.

This is a joke: certainly they have training relative to sports medicine and rheumatology.

Certainly that’s what they would like you to believe, but that’s the tertiary component. Start with basics please.